Rupatadine impurity 14 CAS 1210824-61-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1210824-61-5
Molecular FormulaC7H7Cl2N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rupatadine impurity 14 CAS 1210824-61-5 chemical structure

Description

Rupatadine impurity 14 (C7H7Cl2NHCl) contains a nitrile group, chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Rupatadine impurity 14 (CAS 1210824-61-5) is a certified pharmaceutical impurity reference standard with the molecular formula C7H7Cl2NHCl and a molecular weight of 212.50 g/mol.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC7H7Cl2N HCl
Molecular Weight212.50 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms1

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